System and method for collecting plasma

Abstract

A method for collecting plasma includes determining the weight, height, and hematocrit of a donor, and calculating a donor plasma volume and a target plasma collection volume. The target plasma collection volume is based on the donor plasma volume and a target percentage of plasma. The method then withdraws blood from the donor through a line connected to a blood component separation device, and introduces anticoagulant into the withdrawn blood. The blood component separation device separates the blood into a plasma component and a second blood component, and the plasma component is collected from the blood component separation device and into a plasma collection container. The method may then calculate the volume of pure plasma collected within the plasma collection container, and continue processing/collecting until the calculated volume of pure plasma equals the target plasma collection volume.

What is claimed is: 
     
       1. A system for collecting plasma, comprising:
 a venipuncture needle configured to draw whole blood from a donor; 
 a blood separator configured to separate the whole blood into a plasma product and a second blood component comprising red blood cells, the blood separator having a plasma output port coupled to a plasma line configured to send the plasma product to a plasma product collection container; 
 a donor line fluidly coupled to the venipuncture needle configured to introduce the whole blood from the donor to the blood separator, flow through the donor line being controlled by a first pump; 
 an anticoagulant line coupled to an anticoagulant source, the anticoagulant line configured to combine anticoagulant with the whole blood from the donor, flow through the anticoagulant line being controlled by a second pump; 
 a touchscreen configured to receive input from an operator; and 
 a controller programmed to control operation of the system, the controller coupled to the touchscreen and programmed to receive at least a donor's weight and hematocrit, to determine a target volume for plasma product and/or raw plasma based on the donor's total blood volume and/or the donor's plasma volume, to control the system to operate a draw and return cycle to withdraw the whole blood from the donor and separate the whole blood into the plasma product and the second blood component and to return the second blood component to the donor, to establish a current value of the hematocrit of the donor and a new target volume for plasma product and/or raw plasma, and to control the system to operate a subsequent draw and return cycle, whereby the donor's changing hematocrit is taken into account in calculating the new target volume for plasma product and/or raw plasma. 
 
     
     
       2. The system of  claim 1 , wherein the controller is programmed to determine the target volume for plasma product and/or raw plasma before a start of a first draw and return cycle. 
     
     
       3. The system of  claim 2 , wherein the controller is programmed to repeat draw and return phases until the target volume of plasma product and/or raw plasma is collected, wherein the target volume for plasma product and/or raw plasma is redetermined prior to the start of each draw phase. 
     
     
       4. The system of  claim 3 , wherein the controller is programmed to perform the draw and return phases at least three times. 
     
     
       5. The system of  claim 1 , wherein the controller is programmed to initiate a final return of the second blood component when (1) a measured volume of plasma product in the plasma collection container reaches the target volume for plasma product and/or (2) a volume of raw plasma in the plasma collection container reaches the target volume for raw plasma. 
     
     
       6. A system for collecting plasma, comprising:
 a venipuncture needle configured to draw whole blood from a donor; 
 a blood separator configured to separate the whole blood into a plasma product and a second blood component comprising red blood cells, the blood separator having a plasma output port coupled to a plasma line configured to send the plasma product to a plasma product collection container; 
 a donor line fluidly coupled to the venipuncture needle configured to introduce the whole blood from the donor to the blood separator, flow through the donor line being controlled by a first pump; 
 an anticoagulant line coupled to an anticoagulant source, the anticoagulant line configured to combine anticoagulant with the whole blood from the donor, flow through the anticoagulant line being controlled by a second pump; 
 a touchscreen configured to receive input from an operator; and 
 a controller programmed to control operation of the system, the controller coupled to the touchscreen and programmed to receive at least a donor's weight, height, sex and hematocrit, to determine a target volume for plasma product and/or raw plasma based at least in part on the donor's total blood volume and/or the donor's plasma volume, to control the system to operate draw and return phases to withdraw whole blood from the donor and separate the whole blood into the plasma product and the second blood component and to return the second blood component to the donor. 
 
     
     
       7. The system of  claim 6 , wherein the controller is further programmed to account for anticoagulant introduced into the plasma collection container separately from the plasma product. 
     
     
       8. The system of  claim 7 , wherein the controller is further programmed to account for anticoagulant introduced into the plasma collection container separate from the plasma product attributable to a priming or other pre-processing step. 
     
     
       9. A system for collecting plasma, comprising:
 a venipuncture needle configured to draw whole blood from a donor; 
 a blood separator configured to separate the whole blood into a plasma product and a second blood component comprising red blood cells, the blood separator having a plasma output port coupled to a plasma line configured to send the plasma product to a plasma product collection container; 
 a donor line fluidly coupled to the venipuncture needle configured to introduce the whole blood from the donor to the blood separator, flow through the donor line being controlled by a first pump; 
 an anticoagulant line coupled to an anticoagulant source, the anticoagulant line configured to combine anticoagulant with the whole blood from the donor, flow through the anticoagulant line being controlled by a second pump; 
 a touchscreen configured to receive input from an operator; and 
 a controller programmed to control operation of the system, the controller coupled to the touchscreen and programmed to receive at least a donor's weight, height and hematocrit and to determine a target volume for plasma product comprising raw plasma and anticoagulant, wherein the target volume for plasma product is determined prior to withdrawing the whole blood from the donor based at least in part on the donor's total blood volume and/or the donor's plasma volume, the controller programmed to then control the system to operate a plurality of draw and return cycles to withdraw whole blood from the donor and separate the whole blood into the plasma product and the second blood component and to return the second blood component to the donor. 
 
     
     
       10. The system of  claim 9 , wherein the controller is programmed to determine the target volume for plasma product based an anticoagulant ratio. 
     
     
       11. The system of  claim 9 , wherein the controller is programmed to determine the donor's total blood volume based on multiple parameters selected from the group consisting of the weight, height, sex, age, and morphology of the donor. 
     
     
       12. The system of  claim 9 , wherein the controller is configured to receive the donor's weight and hematocrit electronically. 
     
     
       13. The system of  claim 9 , wherein the controller is programmed to control the system to collect the plasma product in the plasma product collection container until the plasma product in the plasma product collection container reaches the determined target volume. 
     
     
       14. The system of  claim 9 , wherein the controller is programmed to perform the draw and return cycles at least three times and the controller is programmed to determine a volume of whole blood to be drawn in a final draw phase which is different than a volume drawn in a prior draw phase. 
     
     
       15. A system for collecting plasma, comprising:
 a venipuncture needle configured to draw whole blood from a donor; 
 a blood separator configured to separate the whole blood into a plasma product and a second blood component comprising red blood cells, the blood separator having a plasma output port coupled to a plasma line configured to send the plasma product to a plasma product collection container; 
 a donor line fluidly coupled to the venipuncture needle configured to introduce the whole blood from the donor to the separator, flow through the donor line being controlled by a first pump; 
 an anticoagulant line coupled to an anticoagulant source, the anticoagulant line configured to combine anticoagulant with the whole blood from the donor, flow through the anticoagulant line being controlled by a second pump; 
 a touchscreen configured to receive input from an operator; and 
 a controller programmed to control operation of the system, the controller coupled to the touchscreen and programmed to receive donor parameters electronically, to determine a target volume for plasma product and/or raw plasma based at least in part on the donor parameters and on the donor's total blood volume and/or the donor's plasma volume, the controller also configured to control the system to operate draw and return phases to withdraw whole blood from a donor and separate the whole blood into the plasma product and the second blood component and to return the second blood component to the donor. 
 
     
     
       16. The system of  claim 15 , wherein the controller is programmed to control the system to collect the plasma product in the plasma product collection container until a collected volume of plasma product reaches the target volume for plasma product and/or raw plasma. 
     
     
       17. The system of  claim 15 , further comprising a control system, wherein the control system is in electronic communication with the controller. 
     
     
       18. The system of  claim 17 , wherein the control system is programmed to calculate the target volume for plasma product and/or raw plasma and the controller is programmed to determine a target volume for plasma product and/or raw plasma by receiving the target volume for plasma product and/or raw plasma from the control system. 
     
     
       19. The system of  claim 15 , wherein the controller determines the target volume for plasma product and/or raw plasma by calculating the target volume for plasma product and/or raw plasma and wherein the controller is local to and coupled to the blood separator. 
     
     
       20. The system of  claim 15 , wherein the donor parameters received electronically comprise a donor weight, wherein the controller is programmed to determine the target volume for plasma product and/or raw plasma based at least in part on the donor weight. 
     
     
       21. The system of  claim 20 , wherein the donor parameters received electronically comprise a donor hematocrit, wherein the controller is programmed to determine the target volume for plasma product and/or raw plasma based at least in part on the donor hematocrit. 
     
     
       22. The system of  claim 21 , wherein the controller is programmed to determine a target volume for plasma product based on the donor's total blood volume and the donor's plasma volume. 
     
     
       23. The system of  claim 22 , wherein the controller is programmed to determine the donor's total blood volume based on the weight and height of the donor. 
     
     
       24. The system of  claim 23 , wherein the controller is programmed to determine the donor's total blood volume before whole blood is withdrawn from the donor during a donation. 
     
     
       25. The system of  claim 24 , wherein the controller is programmed to determine the target volume for plasma product comprising raw plasma and anticoagulant, wherein the target volume for plasma product is determined prior to withdrawing the whole blood from the donor based at least in part on an anticoagulant ratio, the donor's weight and the donor's hematocrit. 
     
     
       26. The system of  claim 15 , further comprising a reservoir separate from the blood separator for receiving concentrated red blood cells.